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EPEMED - The European Personalised Medicine Association

PROGRAMMATIC COMMITTEE: REGULATORY

Co-Chair: Patrick Larcier, Pharm.D., MBA, Senior Director, Head of the Personalized Medicine Group, Voisin Consulting Life Sciences
Co-Chair: Iain D. Miller, Ph.D., EPEMED Board Member, Founder of Healthcare Strategies Group

EPEMED aims to create a central point of communication for all those involved in progressing personalized medicine; determine optimal routes to deliver Personalized Medicine (PM) treatments to patients efficiently and promote a better understanding of the development of personalized medicine through the creation and application of advanced diagnostic tests.

PM has introduced a new mode of thinking with major impacts on all organizations positioned in the field of healthcare.  Among these organizations, regulatory agencies are keys stakeholders providing the frame and rules to manage patient-related risks. The regulatory context impact directly on market access conditions for the diagnostic industry in terms of constraints (cost, time) but also for value recognition (e;g. LDT vs approved tests) and innovation for the patients (performance evaluation, availability of new assays). This context is subject to major evolution in the coming years.  The EPEMED Regulatory Committee ambition is to impact on the future IVD regulatory landscape for the benefit of patients, industry and translational research.

The regulatory committee of EPEMED will focus on the followings:

  1. 1. Gather EPEMED members position on current and future regulatory context, formulate a consensus  positioning that can be communicated/publicized to PM stakeholders  
  2. 2. Convey to EU regulatory agencies / EMEA / SANCO the EPEMED positioning on new guidance and regulation (Directive 98/79/EC, EMEA guidance on PGx).
  3. 3. Participate and intervene in major events /meetings comprising regulatory discussions to make sure the voice of EPEMED is transmitted
  4. 4. Interact with major trade association (EDMA, BIVDA, EFPIA, Europabio,…) to articulate and leverage EPEMED actions.
  5. 5. Interact with National regulatory bodies to influence decision making process at the European and Nationals levels 

 

For more details, please contact Patrick Larcier at larcier@voisinconsulting.com